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PostPosted: Tue Nov 29, 2011 12:06 am 
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I noticed this in the US Suboxone prescribing information. The language seems to be intentionally ambiguous, but it still spells it out:

Quote:
This finding suggests that
the naloxone in buprenorphine/naloxone tablets may deter injection of buprenorphine/
naloxone tablets by persons with active substantial heroin or other full mu-opioid
dependence. However, clinicians should be aware that some opioid-dependent persons,
particularly those with a low level of full mu-opioid physical dependence or those whose
opioid physical dependence is predominantly to buprenorphine, abuse buprenorphine/
naloxone combinations by the intravenous or intranasal route.


[url]http://www.suboxone.com/pdfs/SuboxonePI.pdf[/quote]

It's really interesting how not many doctors actually understand this fact, despite it being written in black and white in the prescribing information.

There were a couple of other interesting tidbits.

Quote:
Patients should be informed that SUBOXONE sublingual film can cause drug
dependence and that withdrawal signs and symptoms may occur when the
medication is discontinued.


Did your doctor mention that little bit of information?


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PostPosted: Tue Nov 29, 2011 10:41 am 
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My favorite part is that in the prescribing information it tells the doctors that "no adequate studies" have been done on how to discontinue Suboxone. But in the patient insert it says "ask your doctor" how to get off of Suboxone. I honestly believe they want us physically dependent on it with no exit strategy, so they can make a mint.

BTW I recently found out Reckitt-Benckiser makes Nurofen Plus (OTC codeine in U.K.). In the original formulation the pill was made in halves with the codeine on one side and the ibuprofen on the other, so people could easily take high doses of codeine without the other stuff. A lot of people got addicted to codeine and I think they are going to (or already have) put controls on it now. I can't help but think this is all part of RBs marketing plan to keep the patients coming back - the more physically dependent the better- and if the opiates stop working for you, you can always get on Suboxone!


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PostPosted: Tue Nov 29, 2011 1:58 pm 
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I think suboxone was put out way to early by rickk. without knowing alot of key/important facts. They still dont know what long term suboxone use can have on the human body along with alot of other stuff that really should of been known b4 it was put on the market. And it scares me to think one rickk. was allowed to do this two more and more people are still being perscribed it. I remember when i first started suboxone i asked my DR why im having this side effect and the DR said and i quote"your guess is as good as mine and you are not the pnly patient that has asked this question." she said she went through all the lititeure and there nothing about it or why it would happen.

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PostPosted: Tue Nov 29, 2011 2:59 pm 
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I agree it would be nice to know all the long term side effects of any med. The problem with that is how long would every med have to be studied before being put on the market? 10, 20, 30 years? It's just not plausible, what happens to the people who's life could be have been saved while we wait 10 or 20 years to learn all the long term effects? Also I think it would put a huge halt to medical advancement, how many companies would invest that much time and money into a product they wouldn't be able to sell for 10 or 20 years? We think meds are expensive now I can't imagine what they would cost if so much time and money were required to be invested in any new meds.

Honestly I have a view on the other side of the spectrum, I think it takes too long now for meds to be released. Mostly life saving meds, like cancer meds and other life threatening illnesses. I think if a person so chooses to try a new experimental drug with the knowledge that their could be unknown side effects then they should be allowed. Especially terminal patients, if there is a drug that could possibly save their life and they die while waiting for the FDA to approve it just makes no sense to me. What side effect could be worse than death?

I am not suggestiong that drugs shouldn't be studied, just that it should be up to us to decide if the benefit of waiting to learn more outweighs the benefit to taking the med with the knowledge at hand.


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PostPosted: Tue Nov 29, 2011 9:52 pm 
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Breezy_Ann wrote:
I am not suggestiong that drugs shouldn't be studied, just that it should be up to us to decide if the benefit of waiting to learn more outweighs the benefit to taking the med with the knowledge at hand.


I'm with ya there completely breezy. There are a lot of potential life saving medications that cost a heap to overcome the amount of stringent testing that needs to be done. Creating a new medication is fraught with risk, and the expense reflects that.

My issue is not with the passing of medications, moreso the marketing tactics. Pharma companies marketing is questionable at the best of times. RB seem to take the cake. I personally would have so much more faith in my treatment if there weren't questionable practices going on with RB's hype / marketing machine, and information campaigns. It is one of the reasons I want to taper. I find it difficult getting a medication for life off a company whose voice I don't trust. It's no reflection on the chemists, the researchers etc. Just the spin.


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PostPosted: Tue Nov 29, 2011 11:20 pm 
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Not to mention most doctors that perscribe sub are only required to do MINIMAL training. 6-8-10 hrs. or some rediculous thing like that. Honestly anymore it IS A GAME. Marketing, scheeming, bullshitting, manipulating....... and on. There must be a drug that is easier to get off.
.........On the other hand, it makes one think twice before messing around again.....yes?


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PostPosted: Wed Nov 30, 2011 8:54 am 
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RB is a lot of things, but I don't even see them marketing suboxone like they could be. If they chose to do that, they could be making a lot more money than they already are.

I just don't think there's this big conspiracy theory with RB that some people think there is. I think more than anything they are simply out of their element - they are irresponsible working with a medication they just don't know enough about. But working to keep us coming back for more? I highly doubt that - but that's just my opinion.

Oh and as for the minimal training, that's got nothing to do with RB. That came from an Act of Congress (the DATA 2000 Act).

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PostPosted: Wed Nov 30, 2011 9:09 am 
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An interesting article on Bloomberg:

Quote:
Reckitt Benckiser Group Plc (RB/) may be kicking its heroin problem.

After losing U.S. patent protection in 2009 for its Suboxone tablet, designed to help heroin users quit, Reckitt Benckiser has said that the entrance of a generic competitor could erode pharmaceutical sales and profit by 80 percent.

Reckitt Benckiser, which gets most of its revenue from selling home and personal-care products like Lysol cleaners and Durex condoms, has faced calls to sell the business before a generic comes to market. Instead, the London-based company aims to divert the showdown by switching users to a film form of the drug -- one whose last patent doesn’t run out until 2025.

To get people to make the switch, Reckitt Benckiser is thinking more like a consumer company than a pharmaceutical one. It’s drawing on a marketing technique first pioneered by Coca- Cola Co. more than 100 years ago: coupons. By offering up to $45 a month toward a user’s co-payment in the U.S., the company is making the film version, which looks like a Listerine Pocketpak, close to free. That offers patients who get part of the bill subsidized by health insurance little incentive to transfer to a generic pill once it appears on the market.

“They’ve done a good job of making a silk purse out of a not very compelling situation,” said Martin Deboo, an analyst at Investec Securities Ltd. in London.

Reckitt Benckiser’s shares have risen 55 percent in the last five years, outpacing Unilever and Procter & Gamble Co. Under Chief Executive Officer Bart Becht, who stepped down last month, the company more than doubled sales in a decade.
The stock rose 0.3 percent to 3,460 pence at 9:22 a.m. in London today. It has dropped 1.8 percent this year, compared with Unilever’s 5.6 percent gain and P&G’s 3 percent advance.

Drugs Growth

The company is due to report third-quarter results tomorrow and will probably say revenue adjusted for purchases and asset sales rose 7 percent at the drugs division, analysts led by Andy Smith at MF Global in London estimate, compared with a 3.9 percent increase for the rest of the business. Profit likely rose 0.9 percent to 430 million pounds, they said.
The film version of Suboxone, introduced in September 2010, accounted for 41 percent of the drug’s U.S. sales by the end of the first half. That surpassed the company’s own expectations, Becht said on an Aug. 30 conference call arranged by Sanford C. Bernstein. Becht was succeeded by Rakesh Kapoor, a company veteran.

Generic Delay

The film “has been a phenomenal success,” Becht said, according to a transcript of his remarks. “To make the business completely sustainable, we would like to have a share which is clearly much higher than where we are.” He added that the company aims to grow that share every month.

Right now, time is on his side. Teva Pharmaceuticals Industries Ltd., the world’s biggest maker of generics, began the year saying it might launch a Suboxone copy in 2011. Now the company has backed off, saying it no longer expects the product to win regulatory approval this year.

Biodelivery Sciences International Inc. (BDSI), another drugmaker going after Suboxone, said a study comparing its own version of the drug to a placebo failed to show a statistical difference in the treatment of chronic pain. A test in patients addicted to opioids, which include heroin and codeine, is scheduled to begin later this year. Titan Pharmaceuticals Inc. (TTNP) on Aug. 31 said it’s preparing to seek approval of an upper-arm implant that would deliver buprenorphine, one of the active ingredients in Suboxone, directly into the bloodstream.

‘Massive Benefit’

“This delay has been a massive benefit,” said Andrew Wood, an analyst at Sanford C. Bernstein. “With every day that goes by, RB has an extra day to convert users.” Suboxone is either harder-than-expected to copy or generic-drug makers are having second thoughts about targeting addicts, according to Bernstein.

About 1 million people in the U.S. are addicted to heroin, the National Institute on Drug Abuse estimates. As many as 325,000 people use Suboxone to quit the drug or painkillers, says Pablo Zuanic, an analyst at Liberum Capital in London.
The medicine combines buprenorphine, a painkiller derived from the opium poppy that shares some of its properties, with naloxone, a chemical that blunts withdrawal symptoms. The film sells for about $4.63 to $8.23 a dose at Walgreens stores, according to Liberum, depending on its strength and pack size. That means the strongest dose costs about $247 a month.
More than half of people on Suboxone use private insurance with co-pay, Zuanic says. Reckitt Benckiser offers $45 toward co-pay for the film, he said, meaning an insured patient who’d contribute $50 to the cost of the drug may end up spending $5.

'Near Zero’

“The actual cash cost for some patients buying the film with private insurance could be near zero,” Zuanic said in a note to clients this month.

Meantime, Suboxone is only becoming more important to Reckitt Benckiser. The drugs division, whose sales grew five times as quickly as the main business last year, accounted for almost 9 percent of sales and 24 percent of profit, up from 7.6 percent and 20 percent in 2009. Sales at the unit will probably rise 12 percent to 829 million pounds ($1.3 billion) this year, according Nomura International Plc estimates.

The maker of French’s mustard is even considering making an injectable Suboxone and developing new products for cocaine, alcohol and cannabis addicts. The plan has met skepticism.

“We’re quite a long way from having any visibility on these products,” said Julian Hardwick, an analyst at Royal Bank of Scotland Group Plc in London. “Are they products that will work? Which will get approval?”

Prescription drugs are perceived as a bit of a misfit in the home of Vanish stain removers and Finish dishwasher tablets.

Misfit

“Reckitt Benckiser is basically a home and personal-care company with over-the-counter pharmaceuticals,” said Carl Short, an analyst at Standard & Poor’s in London. The drugs unit is “always going to be something that looks like it doesn’t fit with the rest.”

Reckitt Benckiser may look at selling the unit, which Becht himself has said is “not the No. 1 strategic part” of the company, once a generic form of Suboxone reaches pharmacy shelves, analysts said. But the company’s marketing savvy, coupled with delays in the launch of a generic, are giving Kapoor time to settle into his new job.

“This is a big job and he is coming in after someone’s done it for some considerable time and very well,” said Julian Chillingworth, who helps manage about 16 billion pounds in shares at Rathbone Brothers Plc, including Reckitt stock. “You wouldn’t want to come in as a CEO into a very successful business and start selling things off on the cheap.”

Not Time

Analyst valuations range from 2 billion pounds to 6.3 billion pounds, according to four estimates compiled by Bloomberg News. Estimates diverge because it’s hard to value the business without knowing how Suboxone sales will resist the generic challenge and whether the shift to film can counter some of that impact.

“Until you get generic competition for the tablet, I think it’s unlikely that prospective buyers would give you the full value for the business,” said Hardwick of RBS. “Now is not the time to sell.”


What I don't understand is why Teva was denied regulatory approval for generic Suboxone?


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PostPosted: Wed Nov 30, 2011 11:13 am 
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I stand corrected. Fair enough. I know sub is a very complex medication. There are so many variables and unknowns. I used to be angry for not being able to quit ASAP, now however, I'm glad for the time I have been on sub for it really has allowed me to take a good look at my life, the choices I've made and the choices I still have. All in all, another experience in life, one I may choose to not ever repeat(along with many other choices past) thank you for your opinion, I value everyone's right to their own opinion & choices. Blessings to all.


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